From concept through product launch we can plan and execute your medical product development requirements and deliverables or assess your existing projects.
All Class III, Class II, and some Class I medical devices manufacturer must have systems and procedures for controlling the design of their products. The FDA requires documentation of the plan for each design project, documentation of the initial design requirements, verification that the design outputs meet design input requirements, validation that the initial production units conform to user needs and intended uses, proper transfer to manufacturing, and track and documentation of all changes in design.
Integration of Risk Mitigation into Product Development
Design Verification and/or Validation Test Protocols
Design Review Planning and Facilitation
Design and Development of Standard Operating Procedure
Design Reviews and Transfer
Design History File Compilation